Role of automated insulin delivery in managing insulin-treated outpatients with type 2 diabetes: A systematic review and meta-analysis

Table 2 Baseline characteristics of individual single-arm studies and study participants included in the meta-analysis

Ref.	Key inclusion criteria	Study type	Number	Baseline HbA1c (%)	Previous insulin delivery method (%)	Closed-loop system used in the study	Study period	Key findings
Bhargava et al[29], 2025, NCT05238142, United States	T2D for ≥ 2 years; using either MDI or CSII pump therapy, with or without CGM for ≥ 3 months; HbA1c < 10%	Prospective	95	7.9 ± 1.0	MDI (61.1), CSII with CGM (20.0), CSII (9.5), AID pump (7.4), other (2.1)	MiniMed 780G advanced hybrid closed-loop	90 days	No severe hypoglycemia, severe hyperglycemia, diabetic ketoacidosis, or hyperglycemic hyperosmolar state events and no device-related serious or unanticipated adverse device effects. Significant CFB in HbA1c (-0.7%), TIR (7.2%), TAR > 10 mmol/L (-7.1%), TAR > 13.9 mmol/L (-1.7%), mean SG: -0.51 mmol/L, SD of SG: -0.08 mmol/L, TDDI: 13.9 U. No significant CFB in TBR < 3.9 mmol/L or < 3 mmol/L, CV of SG
Telci Caklili et al[30], 2024, Turkey	Age ≥ 60 years, brittle diabetes, and a follow-up of ≥ 3 months with an AID system	Retrospective cohort	34	9.4 ± 2.1	MDI (100)	Medtrum A7 + Touchcare patch pump and integrated A7 + CGM and Medtronic 780G	6 months	Significant CFB in HbA1c (-2.07%), TDDI: -10.77 U. At the end of the study after AID use: TIR (64.8%), TAR > 10 mmol/L (26.7%), TAR > 13.9 mmol/L (6.7%), TBR < 3.9 mmol/L (1.8%), TBR < 3 mmol/L (0.5%)
Davis et al[31], 2023, NCT04617795, United States	Age 18-75 years, on basal-bolus or basal only insulin regimen, has no insulin pump within 3 months of screening, HbA1c 8%-12%	Prospective	24	9.4 ± 0.9	BBI (50), basal only insulin (50)	Omnipod 5, Dexcom G6, and Omnipod 5 app on a locked-down. Android phone	8 weeks	Significant CFB in HbA1c (-1.3%), TIR (21.9%), TAR > 10 mmol/L (-21.4%), TAR > 13.9 mmol/L (-16.9%), TAR > 20 mmol/L (-9.2%), mean SG: -1.83 mmol/L, TBR < 3.9 mmol/L (-0.08%), SD of SG: -0.61 mmol/L. No significant CFB in TBR < 3 mmol/L, CV of SG, TDDI: -8.8 U. No SAE, one hypoglycemic episode
Fabris et al[32], 2024, United States	Adults with T2D transitioned from PLGS to AID	Retrospective	796	NR	PLGS system (Basal-IQ Technology, Tandem Diabetes Care) (100)	AID (CIQ Technology, Tandem Diabetes Care)	3 months	Significant CFB in TIR (9%), TAR > 10 mmol/L (-8.9%), TAR > 13.9 mmol/L (-4.4%), mean SG: -0.65 mmol/L, TDDI: 6.5 U. No significant CFB in TBR < 3.9 mmol/L or < 3 mmol/L, CV of SG
Forlenza et al[33], 2022, United States1	At least 12 consecutive months of data available on CIQ, and had at least 30 days of ≥ 75% CGM data availability before and after CIQ initiation	Retrospective	500	NR, GMI 7.3% (6.9%-7.7%)	NR	Tandem t: Slim X2 CIQ system	3 months	Significant CFB in GMI (-0.2%), TIR (8%), TAR > 10 mmol/L (-5%), TAR > 13.9 mmol/L (-2%), mean SG: -0.47 mmol/L. No significant CFB in TBR < 3.9 mmol/L
Kadiyala et al[34], 2024, NCT04977908 and NCT04701424, United Kingdom1	Age ≥ 18 years, on subcutaneous insulin, HbA1c ≥ 11%	Retrospective	26	9 ± 1.4	Subcutaneous insulin (100)	CamAPS HX fully closed-loop system	8 weeks	At the end of the study after AID use: TIR (66.3%), TAR > 10 mmol/L (32.2%), TAR > 16.7 mmol/L (1.8%), TBR < 3.9 mmol/L (0.43%), TBR < 3 mmol/L (0.04%), mean SG: 9.17 mmol/L, SD of SG: 2.98 mmol/L, CV of glucose (322%)
Levy et al[35], 2024, NCT05111301, United States	either BBI therapy (MDI or via an insulin pump) or basal-only insulin for at least 3 months, TDDI ≤ 200 U, HbA1c 7.5%-12.0%	Prospective	30	8.6 ± 1.2	Basal insulin only (43), MDI (50), insulin pump (7)	T: Slim X2 insulin pump with CIQ technology	6 weeks	Significant CFB in TIR (15%), TAR > 10 mmol/L (-15%), TAR > 13.9 mmol/L (-2.7%), mean SG: -1.22 mmol/L. No significant CFB in TBR < 3.9 mmol/L or <3 mmol/L, CV of SG
Pasquel et al[36], 2025, NCT05815342 United States	Age 18-75 years, treated with a stable insulin regimen for at least 3 months prior to screening, HbA1c < 12%	Prospective	305	8.2 ± 1.3	MDI (73), basal insulin only (21), insulin pump (5.6), premix insulin injections (< 1)	Omnipod 5 AID System	13 weeks	Significant CFB in HbA1c (-0.8%), TIR (20%), TAR > 10 mmol/L (-20%), TAR > 13.9 mmol/L (-12%), TAR > 20 mmol/L (-5%), mean SG: -1.78 mmol/L, TBR < 3.9 mmol/L (0.0%), TBR < 3 mmol/L (0.01%) SD of SG: -0.61 mmol/L, coefficient of variation of SG (-0.7%). 13 patients experienced SAE and one severe hypoglycemia
Thijs et al[37], 2025, multiple countries in Europe	MM780G data uploaded to CareLink Personal from January 2020 to April 2024	Retrospective	26427	NR	NR	MiniMed 780G system	Mean observation period: Cohort A: 213 days, cohort B: 148 days	Cohort A: At the end of the study after AID use-TIR (71.1%), TAR > 10 mmol/L (27.9%), TAR > 13.9 mmol/L (6.6%), TBR < 3.9 mmol/L (1%), TBR < 3 mmol/L (0.2%), mean SG: 8.72 mmol/L, SD of SG: 2.82 mmol/L, GMI (7.1%). Cohort B: At the end of the study after AID use-TIR (75.1%), TAR > 10 mmol/L (24.3%), TAR > 13.9 mmol/L (4.9%), TBR < 3.9 mmol/L (0.6%), TBR < 3 mmol/L (0.1%), mean SG: 8.52 mmol/L, SD of SG: 2.48 mmol/L, GMI (7%). Both cohort A and cohort B had significant CFB in GMI (-0.5% and -0.3%, respectively), TIR (15.9% and 12.1%, respectively)

¹These studies included separate cohorts of type 1 diabetes and type 2 diabetes (T2D). We have considered only T2D cohort for this systematic review.

Data in mean ± SD or median (interquartile range). AID: Automated insulin delivery; BBI: Basal-bolus insulin; CFB: Change from baseline; CIQ: Control-IQ; CGM: Continuous glucose monitoring; CSII: Continuous subcutaneous insulin infusion; GMI: Glucose management indicator; HbA1c: Glycated hemoglobin; MDI: Multiple daily insulin injection; NR: Not reported; PLGS: Predictive low glucose suspend; SAE: Serious adverse event; SG: Sensor glucose; TAR: Time above range; TBR: Time below range; TDDI: Total daily dose of insulin; TIR: Time in range; T2D: Type 2 diabetes.